Safe and explainable AI to help doctors with heart disease, sepsis, and breast cancer care
Official title: SAFE AND EXPLAINABLE AI-ENABLED DECISION MAKING FOR PERSONALIZED CLINICAL DECISION SUPPORT
Run by Abramson Cancer Center at Penn Medicine · NCT06694181 · Data updated 2026-11-12
This project will try AI tools that give safe, explainable decision support for adults treated for cardiology conditions, sepsis, or invasive breast cancer at Penn Medicine.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300000 (estimated) |
| Sponsor | Abramson Cancer Center at Penn Medicine Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Status | Recruiting |
| Started | November 29, 2025 |
| Main results expected | November 2028 |
| Study ends | November 2028 |
| Registry record updated | February 25, 2026 |
| Trial ID | NCT06694181 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age 18 or older) who were treated at Penn Medicine hospitals since 2017 and who meet the study cohorts for cardiology admissions, sepsis presentations, or invasive breast cancer in the Penn Cancer Registry are the intended participants.
✕Probably not a fit
Patients under 18, people treated outside Penn Medicine, and certain subgroups such as cardiology patients admitted for primary cardiac arrest or sepsis patients with pre-existing limits on life-sustaining therapy are unlikely to be included or to benefit from the models developed here.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will develop and validate AI-powered clinical decision support systems using electronic health record data and the Penn Cancer Registry from 2017 onward. The work focuses on integrating medical knowledge into models, making recommendations explainable to clinicians, and building safety guarantees for real-world use. The effort is observational and uses retrospective and prospective data from adult cardiology admissions, sepsis presentations, and invasive breast cancer cases, excluding pediatric patients and certain clinical subgroups (for example cardiac arrest primaries and patients with pre-existing limits on life-sustaining therapy). Models will be tested for predictive performance, transparency of their outputs, and measures intended to reduce unsafe or misleading recommendations.
Why it matters
Potential benefit: If successful, this could help clinicians make safer, more transparent decisions, reduce avoidable errors, and personalize care for adults with cardiac conditions, sepsis, or breast cancer.
How similar studies have gone: Previous work on explainable AI and clinical decision support has shown promise in retrospective and limited prospective settings, but broad safety guarantees and consistent real-world benefit remain incompletely demonstrated.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Cardiology 18 years of age and older, admitted to any of the Penn Medicine hospitals from 2017 to the present. Sepsis 18 years of age at the time of presentation to an emergency department or admission to any Penn Medicine hospital from July 1, 2017, onward will be eligible as this represents the population at risk for acquiring sepsis Oncology 18 years of age and older with a diagnosis of invasive breast cancer (Stage 1-4) in the Penn Cancer registry Exclusion Criteria All prediction models will exclude patients under the age of 18 from their patient data sets. Cardiology Patients whose primary admission diagnosis was cardiac arrest Sepsis Those with pre-existing limitations on life-sustaining therapy will be excluded because their eligibility for sepsis definitions, care received, and outcomes, may be significantly and variably affected by pre-existing limitations on care. Oncology There are no other exclusions.
Where it's running
-
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States Recruiting
Study contacts
- Study coordinator: Haideliza Soto Calderon
- Email: haideliza.soto-calderon@pennmedicine.upenn.edu
- Phone: 215-220-9425
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Gyrotonic exercise for elders with breast cancer and Behcet disease
We’re testing whether a gyrotonic exercise program helps older people who have both Behcet disease and breast cancer.
-
PECS II vs SPSIP nerve blocks for pain after mastectomy
This study tests whether two ultrasound-guided nerve blocks (PECS II and SPSIP) differ in how much opioid patients need after mastectomy.
-
CG-7321: a first-in-human test in advanced solid tumors
We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.
-
Ruta C and Vitamin C in Sepsis: Adding antioxidants to standard care
This trial tests whether adding Ruta C (rutin plus vitamin C) or vitamin C alone to standard sepsis treatment helps adults in the ICU stay shorter and recover better.
-
Compare a new endoscopy-assisted breast-conserving surgery with the usual approach
This study tests whether a new endoscopy-assisted breast-conserving technique can provide similar or better cosmetic outcomes and safety compared with conventional breast-conserving surgery in women with early breast cancer who want to preserve their breast.
-
Different skin care approaches to prevent skin reactions after mastectomy radiation
This study tests three standard skin care methods to see which best prevents radiation dermatitis in people who had a mastectomy and are receiving post-mastectomy radiation therapy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.